Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Drug Specific Control Materials
510(k) Number K072257
Device Name MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
Applicant
More Diagnostics
2020 11th St.
Los Osos,  CA  93402
Applicant Contact JAMES W SNIPES
Correspondent
More Diagnostics
2020 11th St.
Los Osos,  CA  93402
Correspondent Contact JAMES W SNIPES
Regulation Number862.3280
Classification Product Code
LAS  
Date Received08/13/2007
Decision Date 01/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-